← Back to Search

Virus Therapy

Nasal Vaccine for Respiratory Syncytial Virus

Q: Are new participants being accepted for this trial?

Per clinicaltrials.gov this experiment in medicine is currently recruiting patients. It was introduced to the public on April 6th, 2023 and its information was last updated on that same day.

Q: Can minors participate in the research?

This clinical trial is seeking patients in the 6 month to 5 year age range. Additionally, 19 trials are open for individuals below 18 years old and 17 studies are recruiting those aged 65 or above.

Q: Who is the target audience for this clinical trial?

For consideration in this study, prospective participants must have a diagnosis of Respiratory Syncytial Virus (RSV) and be between 6 months and 5 years old. The medical trial is planning to enrol 51 individuals total.

Q: Has the FDA validated Experimental: CodaVax-RSV 10^4 PFU for use?

Clinical data regarding the safety and effectiveness of <a href="https://www.withpower.com/clinical-trials/experimental">Experimental</a>: CodaVax-RSV 10^4 PFU is limited, so it was assigned a score of 1.

Q: How many participants has this trial recruited thus far?

Affirmative. The clinicaltrials.gov website attests to the fact that this trial, which was initially posted on April 6th 2023, is actively recruiting volunteers for participation. 51 individuals need to be sourced from 2 distinct sites.

Phase 1

Recruiting

Research Sponsored by Codagenix, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, days 29 and 57

Awards & highlights

Study Summary

This trial will evaluate the safety and immune response of a nasal vaccine given to children aged 2-5 and 6 months to <2 to protect against RSV; they'll be monitored monthly for 1 yr.

Who is the study for?

This trial is for healthy children who had a full-term birth. Kids aged 2-5 with RSV antibodies and those 6 months to under 2 years without these antibodies can join. They shouldn't be in close contact with certain vulnerable individuals or have conditions affecting their immune system.Check my eligibility

What is being tested?

The study tests CodaVax-RSV, a vaccine given as nose drops to prevent Respiratory Syncytial Virus (RSV). Children will get either the vaccine at different doses or a placebo, across two shots spaced by 28 days. Their health will be monitored over the RSV season.See study design

What are the potential side effects?

Possible side effects are not detailed but parents/guardians will record any symptoms like fever after vaccination. The safety of the vaccine is closely watched, especially when dose levels increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, days 29 and 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, days 29 and 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, days 29 and 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participant reported adverse events

Number of participants reporting expected adverse reactions

Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)

Secondary outcome measures

Neutralizing antibody

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: CodaVax-RSV 10^6 PFUExperimental Treatment1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group II: Experimental: CodaVax-RSV 10^5 PFUExperimental Treatment1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group III: Experimental: CodaVax-RSV 10^4 PFUExperimental Treatment1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group IV: Experimental: CodaVax-RSV 10^3 PFUExperimental Treatment1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group V: Placebo comparatorPlacebo Group1 Intervention

Administered as nose drops

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CodaVax-RSV

2020

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Codagenix, IncLead Sponsor

7 Previous Clinical Trials

331 Total Patients Enrolled

Media Library

CodaVax-RSV (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04919109 — Phase 1

Respiratory Syncytial Virus Research Study Groups: Experimental: CodaVax-RSV 10^3 PFU, Experimental: CodaVax-RSV 10^5 PFU, Experimental: CodaVax-RSV 10^4 PFU, Placebo comparator, Experimental: CodaVax-RSV 10^6 PFU

Respiratory Syncytial Virus Clinical Trial 2023: CodaVax-RSV Highlights & Side Effects. Trial Name: NCT04919109 — Phase 1

CodaVax-RSV (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919109 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this trial?

"Per clinicaltrials.gov this experiment in medicine is currently recruiting patients. It was introduced to the public on April 6th, 2023 and its information was last updated on that same day."

Answered by AI

Can minors participate in the research?

"This clinical trial is seeking patients in the 6 month to 5 year age range. Additionally, 19 trials are open for individuals below 18 years old and 17 studies are recruiting those aged 65 or above."

Answered by AI

Who is the target audience for this clinical trial?

"For consideration in this study, prospective participants must have a diagnosis of Respiratory Syncytial Virus (RSV) and be between 6 months and 5 years old. The medical trial is planning to enrol 51 individuals total."

Answered by AI

Has the FDA validated Experimental: CodaVax-RSV 10^4 PFU for use?

"Clinical data regarding the safety and effectiveness of Experimental: CodaVax-RSV 10^4 PFU is limited, so it was assigned a score of 1."

Answered by AI

How many participants has this trial recruited thus far?

"Affirmative. The clinicaltrials.gov website attests to the fact that this trial, which was initially posted on April 6th 2023, is actively recruiting volunteers for participation. 51 individuals need to be sourced from 2 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

2023. "Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04919109.

All > Rsv